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Nonalcoholic Steatohepatitis (NASH)Phase 2NCT06108219

A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)

A Phase 2 study testing Miricorilant (Cohort A) and Miricorilant (Cohort B) in people with Nonalcoholic Steatohepatitis (NASH) and Metabolic Dysfunction-associated Steatohepatitis (MASH), run by Corcept Therapeutics at 77 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Miricorilant in Adult Patients with Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH) Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Miricorilant (Cohort A) and Miricorilant (Cohort B)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
175 participants
Where
77 sitesin 3 countries
Study dates
25 Oct 2023to 24 Aug 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cohort A: Histological diagnosis of NASH/MASH with NAS ≥ 4 (≥ 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH-CRN fibrosis score of 2 or 3 based on the consensus method of histological assessment. A historical liver biopsy within 6 months of Screening with reading confirmed during the Screening period by a consensus panel is acceptable.
  • Cohort B: Have a liver biopsy result that does not meet with the criteria for inclusion in Cohort A and is consistent with one of the following based on the consensus method of histological assessment:
  • NAS ≥ 3 with ≥1 point in each subcomponent of steatosis, inflammation, and ballooning, and a NASH-CRN fibrosis score of F1 or
  • NAS ≥ 2 with ≥1 point in subcomponent of steatosis and ≥ 1 point in subcomponent of ballooning or inflammation and a NASH-CRN fibrosis score of F2 or 3
  • AST > 17 U/L for women and AST > 20 U/L for men.
  • FibroScan® liver stiffness measurement ≥ 8 kPa and CAP ≥ 280 dB/m.
Show all 12Show fewer
  • MRI-PDFF with ≥ 8% steatosis
  • Presence of at least 1 of the following metabolic syndromes that increase the risk of NASH/MASH:
  • Diagnosis of type 2 diabetes OR
  • Presence of 2 or more components of metabolic syndrome:
  • Fasting blood glucose ≥ 100 mg/dL (5.6 mmol/L) or treatment for elevated blood glucose ii. Systolic blood pressure ≥ 130mmHg, diastolic blood pressure ≥ 85mmHg, or treatment for hypertension iii. Serum triglycerides ≥ 150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides iv. Serum high-density lipoprotein (HDL) cholesterol < 40 mg/dL (1 mmol/L) in men and < 50 mg/dL (1.3 mmol/L) in women or drug treatment for low HDL v. Overweight or obese (body mass index [BMI] ≥ 25 kg/m2 [BMI ≥ 23 kg/m2 in Asians]), or increased waist circumference ≥ 102 cm (40 in) in men and ≥ 88 cm (35 in) in women (male ≥ 90 cm [35.4 in]; women ≥ 80 cm [31.5 in] in
  • Other inclusion criteria may apply

Who cannot join

  • Have participated in another clinical trial within the last 3 months of Screening where the patient received active treatment for NASH/MASH.
  • Have participated in a clinical trial for any other indication within the last 3 months or 5 half-lives of the treatment, whichever is longer.
  • Are pregnant or lactating women
  • Have a BMI < 18 kg/m2 or > 45 kg/m2.• Have had liver transplantation or plan to have liver transplantation during the study
  • Have type 1 diabetes or poorly controlled type 2 diabetes.
  • Are pregnant or lactating women
Show all 14Show fewer
  • Have a BMI < 18 kg/m2 or > 45 kg/m2
  • Have had successful weight-loss surgery within 2 years prior to Screening or are planning weight-loss surgery during the study.
  • Have a >5% weight change within 3 months prior to Screening.
  • Have significant alcohol consumption of more than 20 g per day for women and 30 g per day for men within 1 year prior to screening or score of ≥8 on AUDIT questionnaire
  • Have any other chronic liver disease
  • History of cirrhosis or evidence of cirrhosis by clinical, imaging, or liver biopsy evaluation
  • Have hepatic decompensation
  • Other exclusion criteria may apply

Trial locations and contacts

77 sites in 3 countries.

77 sites in 3 countries

United States48 sites

  • Site # 546

    Arlington, Texas, 76012

  • Site #545

    Austin, Texas, 78756

  • Site #211

    Austin, Texas, 78757

  • Site #447

    Beavercreek, Ohio, 45440

  • Site #452

    Boca Raton, Florida, 33434

  • Site #432

    Brownsville, Texas, 78520

  • Site #207

    Chandler, Arizona, 85224

  • Site #470

    Columbus, Ohio, 43234

  • Site #461

    Cordova, Tennessee, 38018

  • Site #370

    Dallas, Texas, 75230

  • Site #448

    Dayton, Ohio, 45145

  • Site #445

    East Syracuse, New York, 13057

  • Site #213

    Edinburg, Texas, 78539

  • Site #215

    Edinburg, Texas, 78539

  • Site # 101

    Gainesville, Florida, 32610

  • Site #431

    Georgetown, Texas, 78626

  • Site #465

    Hallandale, Florida, 33009

  • Site #430

    Hialeah Gardens, Florida, 33016

  • Site #453

    Houma, Louisiana, 70363

  • Site # 066

    Houston, Texas, 77030

  • Site #305

    Houston, Texas, 77079

  • Site #378

    Huntington Park, California, 90255

  • Site #455

    Jackson, New Jersey, 08724

  • Site #228

    Kansas City, Missouri, 64131

  • Site #459

    Katy, Texas, 77494

  • Site #458

    Lakewood Rch, Florida, 38018

  • Site #439

    Lancaster, California, 93534

  • Site #475

    Largo, Florida, 33777

  • Site #469

    Long Beach, California, 90815

  • Site #373

    Los Angeles, California, 90056

  • Site #463

    Manassas, Virginia, 20110

  • Site #451

    Marrero, Louisiana, 70072

  • Site #061

    Metairie, Louisiana, 70006

  • Site #438

    Miami Lakes, Florida, 33016

  • Site #464

    Morehead City, North Carolina, 29557

  • Site #454

    New York, New York, 10033

  • Site #214

    Panorama City, California, 91402

  • Site #440

    Rockville, Maryland, 20854

  • Site #442

    Saint Paul, Minnesota, 55114

  • Site #433

    San Antonio, Texas, 78125

  • Site #212

    San Antonio, Texas, 78229

  • Site #233

    Santa Ana, California, 92704

  • Site #226

    Seattle, Washington, 98105

  • Site #209

    Tucson, Arizona, 85712

  • Site #460

    Viera, Florida, 32940

  • Site #434

    Waco, Texas, 78125

  • Site #441

    West Jordan, Utah, 84088

  • Site #437

    Westlake, Ohio, 44145

Other trials in United States

India28 sites

  • Site #492

    Ahmedabad, Gujarat, 380053

  • Site #504

    Dehradun, Uttarakhand, 248001

  • Site #506

    Guwahati, Assam, 781032

  • Site #486

    Hyderabad, Telangana, 500003

  • Site #489

    Jaipur, Rajasthan, 302001

  • Site # 485

    Jaipur, Rajasthan, 302004

  • Site #487

    Kolkata, West Bengal, 700020

  • Site #493

    Kolkata, West Bengal, 700073

  • Site #491

    Kolkata, West Bengal, 700150

  • Site #549

    Lucknow, Uttar Pradesh, 226003

  • Site #495

    Ludhiana, Punjab, 141002

  • Site #508

    Madurai, Tamil Nadu, 625020

  • Site #512

    Mumbai, Maharashtra, 400008

  • Site #509

    Mumbai, Maharashtra, 400062

  • Site #511

    Mysore, Karnataka, 570015

  • Site #500

    Nagpur, Maharashtra, 440009

  • Site #482

    New Delhi, 110029

  • Site #510

    New Delhi, 110060

  • Site #501

    New Delhi, 110070

  • Site #496

    Pune, Maharashtra, 412201

  • Site #513

    Rajkot, Gujarat, 360001

  • Site # 494

    Rohtak, Haryana, 124001

  • Site #490

    Surat, Gujarat, 395009

  • Site #514

    Surat, Gujarat, 395009

  • Site #507

    Thiruvananthapuram, Kerala, 695011

  • Site #502

    Vadodara, Gujarat, 390007

  • Site #488

    Varanasi, Uttar Pradesh, 221005

  • Site #503

    Varanasi, Uttar Pradesh, 221005

Other trials in India

Puerto Rico1 site

  • Site #457

    San Juan, 00927-4807

Other trials in Puerto Rico

About this study

Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Miricorilant in Adult Patients with Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)

Read the detailed description

Approximately 75 patients who are eligible for participation in the study will be randomized on Day 1 in a 2:1 ratio to 100 mg miricorilant or placebo twice weekly, for 48 weeks of treatment (Cohort A).

Approximately 90 patients who are eligible for participation in the study will be randomized on Day 1 in a 2:1 ratio to 100 mg miricorilant twice a week for 6 weeks of treatment, followed by a dose escalation to 200 mg miricorilant or placebo twice weekly for an additional 18 weeks which resulting in a total treatment duration of 24 weeks, or to placebo for 24 weeks. (Cohort B).

Being tested
Miricorilant (Cohort A), Placebo (Cohort A), Miricorilant (Cohort B), Placebo (Cohort B)
Keywords
Nonalcoholic Steatohepatitis (NASH), Nonalcoholic Fatty Liver Disease (NAFLD), Metabolic dysfunction-Associated Steatohepatitis (MASH), Metabolic dysfunction-Associated Steatosis Liver Disease (MASLD)
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Miricorilant (Cohort A)Drug

    Also called CORT118335

    Miricorilant 100 mg for oral dosing

  • Placebo (Cohort A)Drug

    Matching placebo for oral dosing for 48 Weeks

  • Miricorilant (Cohort B)Drug

    Also called CORT118335

    Miricorilant 100 mg for oral dosing Miricorilant 200 mg for oral dosing

  • Placebo (Cohort B)Drug

    Matching placebo for oral dosing for 24 Weeks

Study groups in NCT06108219
Study groupRoleWhat they receive
Experimental (Cohort A)ExperimentalPatients who meet the entry criteria for study CORT118335-862 (Cohort A) will be enrolled to receive 100 mg of miricorilant, twice a week for 48 weeks.
Receives: Drug: Miricorilant (Cohort A)
Placebo (Cohort A)Placebo comparatorPatients who meet the entry criteria for study CORT118335-862 (Cohort A) will be enrolled to receive a matching placebo twice a week for 48 weeks.
Receives: Drug: Placebo (Cohort A)
Placebo (Cohort B)Placebo comparatorPatients who meet the entry criteria for study CORT118335-862 (Cohort B) will be enrolled to receive a matching placebo twice a week for 24 weeks.
Receives: Drug: Placebo (Cohort B)
Experimental (Cohort B)ExperimentalPatients who meet the entry criteria for study CORT118335-862 (Cohort B) will be enrolled to receive 100 mg of miricorilant, twice a week for 6 weeks. Dose will be escalated to 200 mg of miricorilant, twice a week for 18 weeks.
Receives: Drug: Miricorilant (Cohort B)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent relative change from Baseline in liver-fat content assessed by MRI-PDFF (Cohort A and Cohort B)

    Measured: Week 24

Secondary outcomes (14)

  1. Percent relative change from Baseline in liver-fat content by MRI-PDFF (Cohort A and B at Week 6 and 24, Cohort A at Week 48)

    Measured: Week 6 and 24, Week 48

  2. Absolute change from Baseline in liver-fat content by MRI-PDFF (Cohort A and B at Week 6 and 24, Cohort A at Week 48)

    Measured: Week 6, 24, Week 48

  3. Resolution of steatohepatitis (defined as a ballooning grade of 0 and a lobular inflammation grade of ≤ 1) and no worsening of liver fibrosis at Week 48 assessed by biopsy (Cohort A).

    Measured: Week 48

  4. Proportion of patients with at least 2 points reduction from Baseline in the NAS (NAFLD activity score) without worsening of liver fibrosis at Week 48 assessed by biopsy, with at least a 1-point reduction in ballooning or inflammation (Cohort A).

    Measured: Week 48

  5. Improvement in liver fibrosis stage by at least 1-point (NASH CRN fibrosis score) from Baseline and no worsening of steatohepatitis at Week 48 assessed by biopsy (Cohort A).

    Measured: Week 48

  6. Change in liver stiffness and Controlled Attenuation Parameter (CAP) by FibroScan. (Cohort A and Cohort B at Week 24, Cohort A at Week 48)

    Measured: Week 24 and 48

  7. Change in absolute body weight (Cohort A and B at Week 24, Cohort A at Week 48)

    Measured: Week 24 and 48

  8. Change in lipids - total cholesterol, HDL, LDL, VLDL, TG, serum free fatty acids, (Cohort A and Cohort B at Week 24, Cohort A at Week 48)

    Measured: Week 24 and 48

  9. Change in Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) (Cohort A and Cohort B at Week 6 and 24, Cohort A at Week 48)

    Measured: Week 6, 24 and 48

  10. Proportion of patients with Baseline ALT > 30 U/L achieving a reduction from Baseline in ALT ≥ 17 U/L at Week 24 (Cohort A and Cohort B) and Week 48 (Cohort A).

    Measured: Week 24, Week 48

  11. Change in ELF, (Cohort A and B at Week 24, Cohort A at Week 48)

    Measured: Week 24 and 48

  12. Change in HbA1c (Cohort A and B at Week 24, Cohort A at Week 48)

    Measured: Week 24 and 48

  13. Change in HOMA-IR (Cohort A and B at Week 24, Cohort A at Week 48)

    Measured: Week 24 and 48

  14. Change in plasma glucose (Cohort A and B at Week 24, Cohort A at Week 48)

    Measured: Week 24 and 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2023
  2. Study start25 Oct 2023
  3. Primary completion13 Feb 2026
  4. Study completion24 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06108219
Sponsor's protocol ID
CORT118335-862
Status last verified
Sep 2026
First submitted
23 Oct 2023
Last updated
29 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Miricorilant (Cohort A) and Miricorilant (Cohort B) in people with Nonalcoholic Steatohepatitis (NASH) and Metabolic Dysfunction-associated Steatohepatitis (MASH), run by Corcept Therapeutics at 77 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States, India, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent relative change from Baseline in liver-fat content assessed by MRI-PDFF (Cohort A and Cohort B) (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06108219.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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